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Monoclonal Antibodies
Ocrelizumab for Multiple Sclerosis
Phase 4
Waitlist Available
Led By Bardia Nourbakhsh
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosis of relapsing remitting multiple sclerosis (RRMS) based on revised McDonald criteria
Expanded Disability Status Scale (EDSS) score at the time of screening =<3
Must not have
Ever received B-cell depleting antibodies (rituximab, ocrelizumab, ofatumumab), alemtuzumab, daclizumab, mitoxantrone or hematopoietic stem-cell transplant
Contraindication to treatment with an anti- cluster of differentiation antigen 20 (CD20) antibodies, including being seropositive for HBsAg
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 18-24 months
Awards & highlights
Summary
This trial will help to understand if the efficacy of ocrelizumab in MS is linked to the normalization of central B-cell tolerance. If so, this would have important implications for the development of new therapies for MS.
Who is the study for?
This trial is for people with relapsing-remitting multiple sclerosis (RRMS) who have an EDSS score of 3 or less, are not pregnant, and agree to use effective contraception. They must have recent MRI changes indicative of MS activity but can't join if they're allergic to ocrelizumab, previously used certain MS drugs or treatments, are pregnant/lactating, or have active hepatitis B.
What is being tested?
The study tests Ocrelizumab's effect on B-cell tolerance defects in RRMS patients. It involves treating participants with two courses of the drug and monitoring them clinically and through MRIs for over two years to see how their immune cells behave post-treatment.
What are the potential side effects?
Ocrelizumab may cause infusion reactions like rash or fever, infections due to weakened immunity, potential reactivation of hepatitis B in those previously infected, and possibly other side effects related to its action on B-cells.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with relapsing-remitting MS.
Select...
My disability level is low, with a score of 3 or less.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have received treatments that target B-cells or had a stem-cell transplant.
Select...
I cannot receive CD20 antibody treatment due to health reasons.
Select...
I have not taken steroids in the last 30 days.
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I have an active hepatitis B infection.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline and 18-24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 18-24 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in B-cell subpopulations
Change in frequency of T-cell phenotypes
Change in peripheral B-cell tolerance checkpoints in people with MS before and after ocrelizumab therapy.
+2 moreSecondary study objectives
Change in disability as assessed by Expanded Disability Status Scale (EDSS)
Change in quality of life as assessed by Neuro-QoL
Time to return of disease activity
Trial Design
1Treatment groups
Experimental Treatment
Group I: OcrelizumabExperimental Treatment1 Intervention
Patients will be treated with two courses of ocrelizumab (Ocrevus) for one year and then will stop the medication and will be monitored for the return of the disease activity. Those who experience the return of the disease activity can go back on the medication.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ocrelizumab
2016
Completed Phase 4
~7260
Find a Location
Who is running the clinical trial?
Johns Hopkins UniversityLead Sponsor
2,307 Previous Clinical Trials
14,861,899 Total Patients Enrolled
30 Trials studying Multiple Sclerosis
2,558 Patients Enrolled for Multiple Sclerosis
Genentech, Inc.Industry Sponsor
1,550 Previous Clinical Trials
568,354 Total Patients Enrolled
27 Trials studying Multiple Sclerosis
4,742 Patients Enrolled for Multiple Sclerosis
Bardia NourbakhshPrincipal InvestigatorJohns Hopkins University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have received treatments that target B-cells or had a stem-cell transplant.I have been diagnosed with relapsing-remitting MS.I cannot receive CD20 antibody treatment due to health reasons.I have not taken steroids in the last 30 days.My disability level is low, with a score of 3 or less.You have new or worsening lesions on a recent brain or spinal cord MRI.I am not pregnant or have been sterilized if I am a woman of childbearing potential.You are allergic to ocrelizumab.I have an active hepatitis B infection.I haven't taken or have stopped taking certain MS drugs for 3 months, or I'm on an injectable MS medication.
Awards:
This trial has 3 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Ocrelizumab
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